Pharma powerhouse Merck has announced that the US FDA has approved KEYTRUDA (pembrolizumab) and KEYTRUDA QLEX (pembrolizumab with berahyaluronidase alfa-pmph) for patients with platinum-resistant ovarian cancer.
The approvals are based on results from the Phase 3 KEYNOTE-B96 (ENGOT-ov65) trial, which showed that KEYTRUDA plus paclitaxel, with or without bevacizumab, reduced the risk of disease progression or death by 28% compared to placebo and improved overall survival by 24% in patients with PD-L1+ tumors.
“For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback — it’s when options can become limited, and the reality patients face can change very quickly,” said Dr Bradley Monk, gynecologic oncologist at Florida Cancer Specialists and Research Institute.
“For patients who have been previously treated with standard platinum-based therapies, the FDA approvals of these pembrolizumab-based regimens offer the possibility of more time.”
KEYTRUDA QLEX is contraindicated in patients with known hypersensitivity to its components. Both KEYTRUDA and KEYTRUDA QLEX carry warnings for severe immune-mediated reactions, infusion-related reactions, transplant complications, embryo-fetal toxicity, and increased mortality in multiple myeloma patients.
“Historically, the prognosis has been poor for patients living with platinum-resistant recurrent ovarian cancer who have limited treatment options that may reduce the risk of disease progression or death. These approvals mark an important moment for the ovarian cancer community, reflecting years of focused investment in KEYTRUDA,” said Dr Gursel Aktan, Merck vice president of global clinical development.
“Introducing the first PD-1 inhibitors for platinum-resistant ovarian cancer means we’re expanding what’s possible for patients facing this disease. It also reinforces our commitment to advancing innovative therapies and improved outcomes across women’s cancers, where the need is greatest.”
In the trial, patients with PD-L1+ tumors receiving KEYTRUDA regimens saw a median progression-free survival of 8.3 months, compared to 7.2 months with placebo, and a median overall survival of 18.2 months, versus 14.0 months for placebo.
The study enrolled 643 patients, with 72% expressing PD-L1, 73% receiving bevacizumab, and 46% having received prior bevacizumab. Almost half had a platinum-free interval of less than three months.
